Clinical Trial: Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

Brief Summary: The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed Summary: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA
Sponsor: Guerbet

Current Primary Outcome:

  • Technical Failure Rate [ Time Frame: 2 - 28 days ]
    Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).
  • Sensitivity [ Time Frame: 2-42 days ]
    Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).
  • Specificity [ Time Frame: 2 - 42 days ]
    Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).


Original Primary Outcome: Measurement of carotid and vertebral artery stenosis [ Time Frame: 0 - 14 days ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Blood Sampling [ Time Frame: 24 hours ]
  • Tolerance at the Injection Site [ Time Frame: 24 hours ]
  • Adverse Events [ Time Frame: 0 - 44 days ]


Information By: Guerbet

Dates:
Date Received: November 12, 2009
Date Started: October 2009
Date Completion:
Last Updated: May 11, 2016
Last Verified: May 2016